{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Denorex Severe Itch Coal Tar TRIETHANOLAMINE SULFATE PEG/PPG-4/12 DIMETHICONE COCO DIETHANOLAMIDE ALCOHOL AVOCADO OIL CHLOROXYLENOL CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCOL DISTEARATE HYPROMELLOSES PANTHENOL RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE .ALPHA.-TOCOPHEROL ACETATE WATER COAL TAR COAL TAR SUNFLOWER OIL PEG-30 LANOLIN TROLAMINE POLYSORBATE 80 PROPYLENE GLYCOL QUATERNIUM-80 MENTHOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Store at 68-77°F (20-25°C)",
        "WARNING : This product can expose you to chemicals including coal tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov."
      ],
      "active_ingredient": [
        "Active Ingredients : Coal Tar 1.8% (from Coal Tar Topical Solution, USP 20%)"
      ],
      "purpose": [
        "Purpose : Anti-itch, anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis"
      ],
      "indications_and_usage": [
        "Uses : Reduces and helps prevent recurrence of these symptoms of dandruff: scalp irritation and itching • flaking • scaling • extra relief of itching due to dandruff"
      ],
      "warnings": [
        "Warnings : For external use only Ask a doctor before use if you have a condition covers a large area of the body. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a condition covers a large area of the body."
      ],
      "when_using": [
        "When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions : for best results, use at least twice a week or as directed by a doctor shake well before use apply to wet hair massage into scalp, leave lather on for several minutes rinse thoroughly and repeat for maximum relief"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aqua/Water/Eau, TEA Lauryl Sulfate, Alcohol, Cocamide DEA, PEG-30 Lanolin, Glycol Distearate, Fragrance/Parfum, Menthol, Panthenol, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Triethanolamine, PEG/PPG-4/12 Dimethicone, Hydroxypropyl Methylcellulose, Chloroxylenol, Polysorbate 80, Propylene Glycol, Quaternium 80, Ricinoleamidopropyl Ethyldimonium Ethosulfate, Citric Acid, Red 40"
      ],
      "questions": [
        "Questions? Call 1-888-398-1382 email info@denorex.com or visit www.denorex.com"
      ],
      "package_label_principal_display_panel": [
        "ADVANCED RELIEF Denorex® SEVERE ITCH MEDICATED ANTI-DANDRUFF SHAMPOO + CONDITIONER 1.8 % Coal Tar / DANDRUFF, SEBORRHEIC DERMATITIS + PSORIASIS INSTANT SOOTHING RELIEF CONTROLS & RELIEVES: SEVERE ITCHING SCALP DISCOMFORT INFLAMMATION FLAKING & SCALING associated with dandruff, seborrheic dermatitis + psoriasis 1.8% COAL TAR 10 FL OZ (296 mL) label"
      ],
      "set_id": "213ccbc4-2f52-58b6-e063-6294a90ae248",
      "id": "213cb08a-41af-72f5-e063-6294a90a41f2",
      "effective_time": "20240903",
      "version": "1",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Denorex Severe Itch"
        ],
        "generic_name": [
          "COAL TAR"
        ],
        "manufacturer_name": [
          "Neoteric Cosmetics, Inc."
        ],
        "product_ndc": [
          "62673-175"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "COAL TAR"
        ],
        "spl_id": [
          "213cb08a-41af-72f5-e063-6294a90a41f2"
        ],
        "spl_set_id": [
          "213ccbc4-2f52-58b6-e063-6294a90ae248"
        ],
        "package_ndc": [
          "62673-175-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R533ESO2EC"
        ]
      }
    }
  ]
}